Bellin Health Escanaba

Summary Statement of Deficiencies D0000 . A proficiency testing desk review survey was performed on June 3, 2026, by the State of Michigan Department of Licensing and Regulatory Affairs. The laboratory was found to be out of compliance with CLIA regulations (42 CFR Part 493, Laboratory Requirements) for the following Conditions: 493.803 Condition: Successful participation. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of the CMS database, Wisconsin State Laboratory of Hygiene Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (WSLH) proficiency testing reports and interview with the laboratory manager, the laboratory failed to achieve satisfactory performance for the chemistry analytes Blood Urea Nitrogen (BUN) and Uric Acid. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database, Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing reports, and interview with the laboratory manager (LM), the laboratory failed to achieve satisfactory performance for 2 (3rd Event 2025 and 1st Event 2026) of 3 testing events for the specialty Chemistry for the analytes Blood Urea Nitrogen (BUN) and Uric Acid. Findings include: 1. A review of the CMS database and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing reports revealed the laboratory obtained the following proficiency testing scores for BUN and Uric Acid: PT Event BUN Score Uric Acid Score 3rd Event 2025 60% 60% 1st Event 2026 0% 0% 2. A phone interview on 06/10/2026 at 11:30 am with the laboratory manager confirmed the scores listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #3 (TC3), the laboratory failed to ensure the risk assessment as part of the Individualized Quality Control Program (IQCP) assessed the potential risks within its own laboratory environment for the Biosite Triage Meter since it was put into use on 10/18/21. Findings include: 1. A review of the laboratory's IQCP revealed the laboratory director approved the plan on 10/18/21 for the laboratory's troponin and D-dimer testing. 2. A review of the laboratory's risk assessment for the Biosite Triage Meter revealed the data used in the risk assessment was from the verification study performed at a different laboratory. 3. An interview on 3/30/22 at 1:08 pm with TC3 confirmed the laboratory did not use data obtained in its own environment for the risk assessment in the IQCP for troponin and D-dimer testing. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #3 (TC3), the laboratory failed to ensure the staining characteristics for peripheral blood smears were acceptable for 2 (11/22/2021 and 10/14/21) of 5 dates reviewed when patient peripheral blood smear evaluations were perfomed. Findings include: 1. A review of patient test records revealed the following patients had peripheral blood smears evaluated and no documentation of stain quality assessed that day: a. Patient 34357723 on 10/14/21. b. Patient 34944064 on 11/22/21. 2. The surveyor requested stain quality documentation for the dates listed above on 3/30/22 at 1:52 pm and it was not made available. 3. An interview on 3/30/22 at 2:27 pm with TC3 confirmed the laboratory did not have documentation of stain characteristics for the dates listed above. -- 2 of 2 --